俄罗斯梅沙尔金国立医学研究中心Dmitry Ponomarev团队分析了术中使用地塞米松对婴儿心脏手术主要并发症和死亡率的影响。相关论文于2020年6月23日发表在《美国医学会杂志》上。

皮质类固醇广泛应用于小儿心脏手术，以减轻全身炎症反应，减少并发症，但其临床效果尚不确定。

为了确定术中使用地塞米松与安慰剂相比，是否能更有效降低小儿心脏手术期间的主要并发症和死亡率，研究组在中国、巴西和俄罗斯的4个医学中心进行了一项双盲、多中心、随机试验。2015年12月至2018年10月，共有394名不到1岁的婴儿接受体外循环心脏手术，将这些婴儿随机分组，其中194名术中接受地塞米松治疗，200名麻醉诱导后接受0.9%的生理盐水。2018年11月完成随访。

主要终点定义为术后30天内死亡、非致命性心肌梗塞、需体外膜氧合、需进行心肺复苏、急性肾损伤、延长机械通气或神经系统并发症的综合结局。394名患儿的中位年龄为6个月，男性占47.2％，均完成试验。地塞米松组中有74名患儿发生主要终点（38.1%），对照组中有91名（45.5%），差异不显著。在17个预先指定的次要终点中，两组之间均无统计学差异。地塞米松组有4名（2.0%）患儿发生感染，而对照组有3名（1.5%）。

总之，在接受体外循环心脏手术的1岁以下婴儿中，与安慰剂相比，术中应用地塞米松并未显著降低30天内主要并发症和死亡的风险。

Title: Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial

Author: Vladimir Lomivorotov, Igor Kornilov, Vladimir Boboshko, Vladimir Shmyrev, Ilya Bondarenko, Ilya Soynov, Alexey Voytov, Stanislav Polyanskih, Oleg Strunin, Alexander Bogachev-Prokophiev, Giovanni Landoni, Caetano Nigro Neto, Gretel Oliveira Nicolau, Leonardo Saurith Izquierdo, Vinícius Nogueira Nascimento, Zhang Wen, Hu Renjie, Zhang Haibo, Vladlen Bazylev, Mikhail Evdokimov, Shahrijar Sulejmanov, Aleksei Chernogrivov, Dmitry Ponomarev

Issue&Volume: 2020/06/23

Abstract: Importance  Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.

Objective  To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery.

Design, Setting, and Participants  The Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018.

Interventions  The dexamethasone group (n=194) received 1 mg/kg of dexamethasone; the control group (n=200) received an equivolume of 0.9% sodium chloride intravenously after anesthesia induction.

Main Outcomes and Measures  The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization.

Results  All of the 394 patients randomized (median age, 6 months; 47.2% boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95% CI, 0.8% to 15.3%; hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P=.20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group.

Conclusions and Relevance  Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference.

DOI: 10.1001/jama.2020.8133

Source: https://jamanetwork.com/journals/jama/article-abstract/2767328